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Completed

NCT Number: NCT04587154

Womens Study to Alleviate Vasomotor Symptoms

This study tests the hypothesis that a low-fat, vegan diet including soybeans reduces the frequency and severity of menopausal hot flashes, and tests the hypothesis that total isoflavone intake is associated with the reduction in the frequency and severity of hot flashes.

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Key information

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Physicians Committee for Responsible Medicine

Washington D.C., District of Columbia, 20016, United States

About this study

Women with postmenopausal hot flashes will be recruited via social media and randomly assigned to an intervention or control group. The intervention group will be asked to consume a low-fat, vegan diet including ½ cup (86g) cooked soybeans (30 g uncooked) for 12 weeks. Support will be provided by weekly meetings conducted via an Internet video conferencing platform (e.g., Zoom), along with individual counseling as needed. The control group will be asked to make no diet changes for 12 weeks but will be offered instruction in how to follow a vegan diet and about the potential role of soybeans after the 12-week point. The frequency and severity of hot flashes will be assessed before, during, and after the 12-week intervention.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Post-menopausal women aged 40-60 years
  • English fluency
  • Moderate-to-severe hot flashes experienced at least twice per day
  • Started menopause within the last 10 years
  • No menses in preceding 12 months
  • Access to an iPhone or Android phone and willingness to install a hot-flash recording app.
  • Willingness to participate in weekly classes
  • Willingness to follow a low-fat vegan diet, including daily consumption of soybeans.

Exclusion criteria

  • Use of hormonal medications in the preceding 2 months
  • An explanation for hot flashes other than menopause (e.g., medication use, cancer treatment)
  • Smoking during the past six months
  • History of an eating disorder or evidence of a current eating disorder (as determined by an eating disorder diagnosis, the discretion of a qualified medical professional, or an Eating Attitudes Test-26 score >20)
  • Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
  • Use of recreational drugs in the past 6 months
  • Use of weight-loss medications over the last 6 months or a current attempt to lose weight
  • Body Mass Index < 18.5 kg/m2
  • Soy allergy

Treatment and study plan

low-fat vegan diet with 1/2 cup soybeans daily

Other

Weekly instructions will be given to the participants in the intervention group about following vegan diet with 1/2 cup of soybeans daily.

Other names: Vegan diet

Primary outcomes

  1. Rate of Hot Flash

    Time frame: 12 weeks

    Incidents Induced by Menopause. Hot flashes will be recorded using the MyLuna application, available in the App Store for iPhone or Android.

  2. Menopause Quality of Life Questionnaire (MENQOL)

    Time frame: 12 weeks

    Participants will fill out a Menopause Quality of Life Questionnaire (MENQOL)

Secondary outcomes

  1. Weight Change

    Time frame: 12 weeks

    Body weight changes, which will be measured weekly using a Renfro scale sent out to participants in both groups.

  2. Dietary Advanced Glycation End Products (AGEs)

    Time frame: 16 weeks

    Explore the effectiveness of a vegan diet in reducing dietary AGEs.

  3. PDI, hPDI, uPDI

    Time frame: 16 weeks

    Assess the total plant-based index (PDI), healthy PDI, and unhealthy PDI, and their relationship with weight loss.

  4. Ultraprocessed foods

    Time frame: 16 weeks

    The consumption of ultraprocessed foods will be assessed, using the NOVA classification, at baseline and 16 weeks.

  5. Carbon Footprint

    Time frame: 16 weeks

    The greenhouse gas emissions (GHGE) and cumulative energy demand (CED) will be assessed, using the database of Food Impacts on the Environment for Linking to Diets (dataFIELD) and What We Eat In America (WWEIA) database, at baseline and 16 weeks.

Sponsors and collaborators

Lead sponsor

Physicians Committee for Responsible Medicine

Other

Registry information

Acronym: WAVS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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